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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K163035
Device Name DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
Applicant
Elm Tree Medical, Inc.
1543 Sloat Blvd. #320725
San Francisco,  CA  94132
Applicant Contact Eva Martin
Correspondent
ProMedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
FTY  
Date Received10/31/2016
Decision Date 07/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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